Oscillating positive expiratory pressure device

ABSTRACT

A respiratory treatment device comprising at least one chamber, a chamber inlet configured to receive exhaled air into the at least one chamber, at least one chamber outlet configured to permit exhaled air to exit the at least one chamber, and an exhalation flow path defined between the chamber inlet and the at least one chamber outlet. A restrictor member positioned in the exhalation flow path is moveable between a closed position, where a flow of exhaled air along the exhalation flow path is restricted, and an open position, where the flow of exhaled air along the exhalation flow path is less restricted. A vane in fluid communication with the exhalation flow path is operatively connected to the restrictor member and is configured to reciprocate between a first position and a second position in response to the flow of exhaled air along the exhalation flow path.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/532,951, filed on Sep. 9, 2011, and U.S. Provisional Application No.61/493,816, filed on Jun. 6, 2011, both of which are incorporated hereinby reference.

TECHNICAL FIELD

The present disclosure relates to a respiratory treatment device, and inparticular, to an oscillating positive expiratory pressure (“OPEP”)device.

BACKGROUND

Each day, humans may produce upwards of 30 milliliters of sputum, whichis a type of bronchial secretion. Normally, an effective cough issufficient to loosen secretions and clear them from the body's airways.However, for individuals suffering from more significant bronchialobstructions, such as collapsed airways, a single cough may beinsufficient to clear the obstructions.

OPEP therapy represents an effective bronchial hygiene technique for theremoval of bronchial secretions in the human body and is an importantaspect in the treatment and continuing care of patients with bronchialobstructions, such as those suffering from chronic obstructive lungdisease. It is believed that OPEP therapy, or the oscillation ofexhalation pressure at the mouth during exhalation, effectivelytransmits an oscillating back pressure to the lungs, thereby splittingopen obstructed airways and loosening the secretions contributing tobronchial obstructions.

OPEP therapy is an attractive form of treatment because it can be easilytaught to most patients, and such patients can assume responsibility forthe administration of OPEP therapy throughout a hospitalization and alsofrom home. To that end, a number of portable OPEP devices have beendeveloped.

BRIEF SUMMARY

In order to provide an effective means for delivering OPEP therapy, amethod and device for administering OPEP therapy is disclosed. In afirst aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveexhaled air into the at least one chamber, at least one chamber outletconfigured to permit exhaled air to exit the at least one chamber, andan exhalation flow path defined between the chamber inlet and the atleast one chamber outlet. A restrictor member positioned in theexhalation flow path is moveable between a closed position, where a flowof exhaled air along the exhalation flow path is restricted, and an openposition, where the flow of exhaled air along the exhalation flow pathis less restricted. Furthermore, a vane in fluid communication with theexhalation flow path is operatively connected to the restrictor memberand is configured to reciprocate between a first position and a secondposition in response to a flow of exhaled air along the exhalation flowpath. The restrictor member and the vane are axially offset along acommon axis of rotation.

In another aspect, in the first position, the vane is positioned todirect the flow of exhaled air to exit the at least one chamber througha first chamber outlet of the at least one chamber outlet, and in thesecond position, the vane is positioned to direct the flow of exhaledair to exit the at least one chamber through a second chamber outlet ofthe at least one chamber outlet.

In another aspect, the restrictor member is positioned in a firstchamber, while the vane is positioned in a second chamber. The firstchamber and the second chamber may be connected by an orifice, and thesize of the orifice may be configured to change in response to the flowof exhaled air through the orifice. The restrictor member may beimplemented as a butterfly valve. Also, the restrictor member may beoperatively connected to the restrictor member by a shaft.

In yet another aspect, a face of the restrictor member is rotatableabout an axis of rotation. The face of the restrictor member may also beradially offset from the axis of rotation. In addition, the face of therestrictor member may have a greater surface area positioned on one sideof the shaft than the other side of the shaft.

In another aspect, an orientation of the chamber inlet is selectivelyadjustable.

In a further aspect, the respiratory treatment device includes a chamberinlet bypass configured to permit exhaled air into the at least onechamber without passing through the chamber inlet.

In another aspect, the respiratory treatment device includes a controlport configured to permit exhaled air to exit the respiratory treatmentdevice prior to entering the at least one chamber. The respiratorytreatment device may also include a control port configured to permitexhaled air to exit the first chamber.

In a further aspect, the respiratory treatment device includes aninhalation port in fluid communication with a user interface. Therespiratory treatment device may also include a one-way valve configuredto permit air to flow through the inhalation port to the user interfaceupon inhalation. The inhalation port may be adapted to receive anaerosol medicament from an aerosol delivery device. The aerosol deliverydevice may be connected to the inhalation port.

In another aspect, the exhalation flow path is folded upon itself.

In another aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveexhaled air into the at least one chamber, at least one chamber outletconfigured to permit exhaled air to exit the at least one chamber, andan exhalation flow path defined between the chamber inlet and the atleast one chamber outlet. A restrictor member positioned in theexhalation flow path is moveable between a closed position, where a flowof exhaled air through the chamber inlet is restricted, and an openposition, where the flow of exhaled air through the chamber inlet isless restricted. In addition, an orifice is positioned along theexhalation flow path through which exhaled air passes. A vane positionedadjacent the orifice is operatively connected to the restrictor memberand is configured to reciprocate between a first position and a secondposition in response to an increased pressure adjacent the vane. Therestrictor member moves between the closed position and the openposition in response to the vane reciprocating between the firstposition and the second position.

In a further aspect, the restrictor member may be positioned in a firstchamber and the vane may be positioned in a second chamber, with theorifice separating the first and the second chamber. In addition, thesize of the orifice may be configured to change in response to the flowof exhaled air through the orifice.

In another aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveexhaled air into the at least one chamber, at least one chamber outletconfigured to permit exhaled air to exit the at least one chamber, andan exhalation flow path defined between the chamber inlet and the atleast one chamber outlet. A restrictor member positioned in theexhalation flow path is moveable in response to a flow of exhaled airalong the exhalation flow path between a closed position, where the flowof exhaled air along the exhalation flow path is restricted, and an openposition, where the flow of exhaled air along the exhalation flow pathis less restricted. Furthermore, a variable nozzle is positioned in theexhalation flow path such that the exhalation flow path passes throughan orifice of the variable nozzle. A size of the orifice is configuredto increase in response to the flow of exhaled air thought the orifice.

In yet another aspect, the respiratory treatment device may comprise avane positioned adjacent the orifice. The vane may be operativelyconnected to the restrictor member such that it is configured to movethe restrictor member between the closed position and the open positionin response to an increased pressure adjacent the vane.

In another aspect, the variable nozzle is positioned downstream from therestrictor member in the exhalation flow path.

In a further aspect, the orifice of the variable nozzle is substantiallyrectangular. The orifice of the variable nozzle may remain substantiallyrectangular after an increase in the size of the orifice in repose tothe flow of exhaled air through the orifice.

In yet another aspect, a method of performing OPEP therapy includesreceiving a flow of exhaled air along an exhalation flow path definedbetween an inlet and an outlet of a respiratory treatment device,directing the flow of exhaled air toward a vane, and reciprocating thevane between a first position and a second position in response to theflow of exhaled air. The method further includes moving a restrictormember in response to the reciprocal movement of the vane between aclosed position, where a flow of exhaled air through the chamber inletis restricted, and an open position, where the flow of exhaled air isless restricted.

In another aspect, a method of performing OPEP therapy includesreceiving a flow of exhaled air along an exhalation flow path definedbetween an inlet and an outlet of a respiratory treatment device,accelerating the flow of exhaled air though an orifice positioned alongthe exhalation flow path, and reciprocating a vane adjacent the orificebetween a first position and a second position in response to the flowof exhaled air through the orifice. The method further includes moving arestrictor member in response to the reciprocal movement of the vanebetween a closed position, where a flow of exhaled air along theexhalation flow path is restricted, and an open position, where the flowof exhaled air along the exhalation flow path is less restricted. Themethod may also include changing a size of the orifice in response tothe flow of exhaled air thought the orifice.

In yet another aspect, a respiratory treatment device includes a housingenclosing a plurality of chambers, a first opening in the housingconfigured to transmit air exhaled into and air inhaled from thehousing, a second opening in the housing configured to permit airexhaled into the first opening to exit the housing, and a third openingin the housing configured to permit air outside the housing to enter thehousing upon inhalation at the first opening. An exhalation flow path isdefined between the first opening and the second opening, and aninhalation flow path defined between the third opening and the firstopening. A restrictor member is positioned in the exhalation flow pathand the inhalation flow path, and is movable between a closed position,where a flow of air along the exhalation flow path or the inhalationflow path is restricted, and an open position, where the flow of exhaledair along the exhalation flow path or the inhalation flow path is lessrestricted. A vane is in fluid communication with the exhalation flowpath and the inhalation flow path. The vane is operatively connected tothe restrictor member and configured to repeatedly reciprocate between afirst position and a second position in response to the flow of airalong the exhalation flow path or the inhalation flow path.

In a further aspect, the exhalation flow path and the inhalation flowpath form an overlapping portion. The flow of air along the exhalationflow path and the inhalation flow path along the overlapping portion maybe in the same direction. Furthermore, the restrictor member may bepositioned in the overlapping portion, and the vane may be in fluidcommunication with the overlapping portion.

In another aspect, the restrictor member is positioned in a firstchamber of the plurality of chambers, and the vane is positioned in asecond chamber of the plurality of chambers. The flow of air through aninlet to the first chamber may be restricted when the restrictor memberis in the closed position, and the flow of air through the inlet may beless restricted when the restrictor member is in the open position. Inaddition, the first chamber and the second chamber may be connected byan orifice. Furthermore, the vane may be positioned adjacent the orificesuch that the vane is configured to move the restrictor member betweenthe closed position and the open position in response to an increasedpressure adjacent the vane.

In yet another aspect, the second opening includes a one-way exhalationvalve configured to permit air exhaled into the housing to exit thehousing upon exhalation at the first opening.

In another aspect, the third opening includes a one-way inhalation valveconfigured to permit air outside the housing to enter the housing uponinhalation at the first opening.

In an additional aspect, a one-way valve is positioned along theexhalation flow path between the first opening and the second opening,such that the one-way valve is configured to open in response to airexhaled into the first opening, and close in response to air inhaledthrough the first opening.

In a further aspect, a one-way valve is positioned along the inhalationflow path between the third opening and the first opening, such that theone-way valve is configured to open in response to air inhaled throughthe first opening, and close in response to air exhaled into the firstopening.

In yet another aspect, the respiratory treatment device may include aninhalation port in fluid communication with a user interface, whereinthe inhalation port is adapted to receive an medicament suitable forinhalation from an aerosol delivery device. The aerosol delivery devicemay be connected to the inhalation port.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an OPEP device;

FIG. 2 is a rear perspective view of the OPEP device of FIG. 1;

FIG. 3 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown without the internal components of theOPEP device;

FIG. 4 is an exploded view of the OPEP device of FIG. 1, shown with theinternal components of the OPEP device;

FIG. 5 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown with the internal components of the OPEPdevice;

FIG. 6 is a different cross-sectional perspective view taken along lineVI in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 7 is a different cross-sectional perspective view taken along lineVII in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 8 is a front perspective view of a restrictor member operativelyconnected to a vane;

FIG. 9 is a rear perspective view of the restrictor member operativelyconnected to the vane shown in FIG. 8;

FIG. 10 is a front view of the restrictor member operatively connectedto the vane shown in FIG. 8;

FIG. 11 is a top view of the restrictor member operatively connected tothe vane shown in FIG. 8;

FIG. 12 is a front perspective view of a variable nozzle shown withoutthe flow of exhaled air therethrough;

FIG. 13 is a rear perspective view of the variable nozzle of FIG. 12shown without the flow of exhaled air therethrough;

FIG. 14 is a front perspective view of the variable nozzle of FIG. 12shown with a high flow of exhaled air therethrough;

FIGS. 15A-C are top phantom views of the OPEP device of FIG. 1 showingan exemplary illustration of the operation of the OPEP device of FIG. 1;

FIG. 16 is a front perspective view of a different embodiment of avariable nozzle shown without the flow of exhaled air therethrough;

FIG. 17 is a rear perspective view of the variable nozzle of FIG. 16shown without the flow of exhaled air therethrough;

FIG. 18 is a front perspective view of a second embodiment of an OPEPdevice;

FIG. 19 is a rear perspective view of the OPEP device of FIG. 18;

FIG. 20 is an exploded view of the OPEP device of FIG. 18, shown withthe internal components of the OPEP device;

FIG. 21 is a cross-sectional view taken along line I in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 22 is a cross-sectional view taken along line II in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 23 is a cross-sectional view taken along line III in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 24 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 18;

FIG. 25 is a rear perspective view of the adjustment mechanism of FIG.24;

FIG. 26 is a front perspective view of a restrictor member operativelyconnected to a vane for use in the OPEP device of FIG. 18;

FIG. 27 is a front perspective view of the adjustment mechanism of FIG.24 assembled with the restrictor member and the vane of FIG. 26;

FIG. 28 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 29A-B are partial cross-sectional views illustrating installationof the assembly of FIG. 27 within the OPEP device of FIG. 18;

FIG. 30 is a front view of the OPEP device of FIG. 18 illustrating anaspect of the adjustability of the OPEP device;

FIG. 31 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 32A-B are partial cross-sectional views taken along line III inFIG. 18 of the OPEP device, illustrating possible configurations of theOPEP device;

FIGS. 33A-B are top phantom views illustrating the adjustability of theOPEP device of FIG. 18;

FIGS. 34A-B are top phantom views of the OPEP device of FIG. 18,illustrating the adjustability of the OPEP device;

FIG. 35 is a front perspective view of a third embodiment of an OPEPdevice;

FIG. 36 is a cross-sectional view taken along line I in FIG. 35 of theOPEP device;

FIG. 37 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 35 assembled with a restrictor member and a vane;

FIG. 38 is a rear perspective view of the assembly of FIG. 37;

FIG. 39 is a front perspective view of a fourth embodiment of an OPEPdevice;

FIG. 40 is a cross-sectional view taken along line I in FIG. 39 of theOPEP device;

FIGS. 41A-B are top phantom views of the OPEP device of FIG. 39,illustrating the adjustability of the OPEP device;

FIG. 42 is a front perspective view of an alternative embodiment of theOPEP device of FIG. 1;

FIG. 43 is a cross-sectional view taken along line I in FIG. 42 of theOPEP device;

FIG. 44 is a front perspective view of another alternative embodiment ofthe OPEP device of FIG. 1;

FIG. 45 is a cross-sectional view taken along line I in FIG. 44 of theOPEP device;

FIG. 46 is a front perspective view of yet another alternativeembodiment of the OPEP device of FIG. 1;

FIG. 47 is a cross-sectional view taken along line I in FIG. 46 of theOPEP device;

FIG. 48 is a front perspective view of another embodiment of an OPEPdevice;

FIG. 49 is a rear perspective view of the OPEP device of FIG. 48;

FIG. 50 is a perspective view of the bottom of the OPEP device of FIG.48;

FIG. 51 is an exploded view of the OPEP device of FIG. 48;

FIG. 52 is a cross-sectional view taken along line I in FIG. 48, shownwithout the internal components of the OPEP device;

FIG. 53 is a cross-sectional view taken along line I in FIG. 48, shownwith the internal components of the OPEP device;

FIG. 54 is a front-perspective view of an inner casing of the OPEPdevice of FIG. 48;

FIG. 55 is a cross-sectional view of the inner casing taken along line Iof in FIG. 54;

FIG. 56 is a perspective view of a vane of the OPEP device of FIG. 48;

FIG. 57 is a front perspective view of a restrictor member of the OPEPdevice of FIG. 48;

FIG. 58 is a rear perspective view of the restrictor member of the FIG.57;

FIG. 59 is a front view of the restrictor member of FIG. 57;

FIG. 60 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 48;

FIG. 61 is a rear perspective view of the adjustment mechanism of FIG.60;

FIG. 62 is a front perspective view of the adjustment mechanism of FIGS.60-61 assembled with the restrictor member of FIGS. 57-59 and the vaneof FIG. 56;

FIG. 63 is a front perspective view of a variable nozzle of the OPEPdevice of FIG. 48;

FIG. 64 is a rear perspective view of the variable nozzle of FIG. 63;

FIG. 65 is a front perspective view of the one-way valve of the OPEPdevice of FIG. 48.

FIG. 66 is a perspective view of another embodiment of a respiratorytreatment device;

FIG. 67 is an exploded view of the respiratory treatment device of FIG.66;

FIG. 68 is a cross-sectional perspective view taken along line I in FIG.66 of the respiratory treatment device shown with the internalcomponents of the device;

FIG. 69 is a cross-sectional perspective view taken along line II inFIG. 66 of the respiratory treatment device shown with the internalcomponents of the device;

FIG. 70 is a different cross-sectional perspective view taken along lineI in FIG. 66 of the respiratory treatment device, showing a portion ofan exemplary exhalation flow path;

FIG. 71 is a different cross-sectional perspective view taken along lineII in FIG. 66, showing a portion of an exemplary exhalation flow path;

FIG. 72 is another cross-sectional perspective view taken along line Iin FIG. 66, showing a portion of an exemplary inhalation flow path;

FIG. 73 is another cross-sectional perspective view taken along line IIin FIG. 66, showing a portion of an exemplary inhalation flow path; and,

FIG. 74 is a front perspective view of the OPEP device of FIG. 48,connected with an exemplary aerosol delivery device in the form of anebulizer.

DETAILED DESCRIPTION

OPEP therapy is effective within a range of operating conditions. Forexample, an adult human may have an exhalation flow rate ranging from 10to 60 liters per minute, and may maintain a static exhalation pressurein the range of 8 to 18 cm H₂O. Within these parameters, OPEP therapy isbelieved to be most effective when changes in the exhalation pressure(i.e., the amplitude) range from 5 to 20 cm H₂O oscillating at afrequency of 10 to 40 Hz. In contrast, an adolescent may have a muchlower exhalation flow rate, and may maintain a lower static exhalationpressure, thereby altering the operating conditions most effective forthe administration of OPEP therapy. Likewise, the ideal operatingconditions for someone suffering from a respiratory illness, or incontrast, a healthy athlete, may differ from those of an average adult.As described below, the components of the disclosed OPEP devices areselectable and/or adjustable so that ideal operating conditions (e.g.,amplitude and frequency of oscillating pressure) may be identified andmaintained. Each of the various embodiments described herein achievefrequency and amplitude ranges that fall within the desired ranges setforth above. Each of the various embodiments described herein may alsobe configured to achieve frequencies and amplitudes that fall outsidethe ranges set forth above.

First Embodiment

Referring first to FIGS. 1-4, a front perspective view, a rearperspective view, a cross-sectional front perspective view, and anexploded view of an OPEP device 100 are shown. For purposes ofillustration, the internal components of the OPEP device 100 are omittedin FIG. 3. The OPEP device 100 generally comprises a housing 102, achamber inlet 104, a first chamber outlet 106, a second chamber outlet108 (best seen in FIGS. 2 and 7), and a mouthpiece 109 in fluidcommunication with the chamber inlet 104. While the mouthpiece 109 isshown in FIGS. 1-4 as being integrally formed with the housing 102, itis envisioned that the mouthpiece 109 may be removable and replaceablewith a mouthpiece 109 of a different size or shape, as required tomaintain ideal operating conditions. In general, the housing 102 and themouthpiece 109 may be constructed of any durable material, such as apolymer. One such material is Polypropylene. Alternatively,acrylonitrile butadiene styrene (ABS) may be used.

Alternatively, other or additional interfaces, such as breathing tubesor gas masks (not shown) may be attached in fluid communication with themouthpiece 109 and/or associated with the housing 102. For example, thehousing 102 may include an inhalation port (not shown) having a separateone-way inhalation valve (not shown) in fluid communication with themouthpiece 109 to permit a user of the OPEP device 100 both to inhalethe surrounding air through the one-way valve, and to exhale through thechamber inlet 104 without withdrawing the mouthpiece 109 of the OPEPdevice 100 between periods of inhalation and exhalation. In addition,any number of aerosol delivery devices may be connected to the OPEPdevice 100, for example, through the inhalation port mentioned above,for the simultaneous administration of aerosol and OPEP therapies. Assuch, the inhalation port may include, for example, an elastomericadapter, or other flexible adapter, capable of accommodating thedifferent mouthpieces or outlets of the particular aerosol deliverydevice that a user intends to use with the OPEP device 100. As usedherein, the term aerosol delivery devices should be understood toinclude, for example, without limitation, any nebulizer, soft mistinhaler, pressurized metered dose inhaler, dry powder inhaler,combination of a holding chamber a pressurized metered dose inhaler, orthe like. Suitable commercially available aerosol delivery devicesinclude, without limitation, the AEROECLIPSE nebulizer, RESPIMAT softmist inhaler, LC Sprint nebulizer, AEROCHAMBER PLUS holding chambers,MICRO MIST nebulizer, SIDESTREAM nebulizers, Inspiration Elitenebulizers, FLOVENT pMDI, VENTOLIN pMDI, AZMACORT pMDI, BECLOVENT pMDI,QVAR pMDI and AEROBID PMDI, XOPENEX pMDI, PROAIR pMDI, PROVENT pMDI,SYMBICORT pMDI, TURBOHALER DPI, and DISKHALER DPI. Descriptions ofsuitable aerosol delivery devices may be found in U.S. Pat. Nos.4,566,452; 5,012,803; 5,012,804; 5,312,046; 5,497,944; 5,622,162;5,823,179; 6,293,279; 6,435,177; 6,484,717; 6,848,443; 7,360,537;7,568,480; and, 7,905,228, the entireties of which are hereinincorporated by reference.

In FIGS. 1-4, the housing 102 is generally box-shaped. However, ahousing 102 of any shape may be used. Furthermore, the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108could be any shape or series of shapes, such as a plurality (i.e., morethan one) of circular passages or linear slots. More importantly, itshould be appreciated that the cross-sectional area of the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108 areonly a few of the factors influencing the ideal operating conditionsdescribed above.

Preferably, the housing 102 is openable so that the components containedtherein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions. Assuch, the housing 102 is shown in FIGS. 1-4 as comprising a frontsection 101, a middle section 103, and a rear section 105. The frontsection 101, the middle section 103, and the rear section 105 may beremovably connected to one another by any suitable means, such as asnap-fit, a compression fit, etc., such that a seal forms between therelative sections sufficient to permit the OPEP device 100 to properlyadminister OPEP therapy.

As shown in FIG. 3, an exhalation flow path 110, identified by a dashedline, is defined between the mouthpiece 109 and at least one of thefirst chamber outlet 106 and the second chamber outlet 108 (best seen inFIG. 7). More specifically, the exhalation flow path 110 begins at themouthpiece 109, passes through the chamber inlet 104, and enters into afirst chamber 114, or an entry chamber. In the first chamber 114, theexhalation flow path makes a 180-degree turn, passes through a chamberpassage 116, and enters into a second chamber 118, or an exit chamber.In the second chamber 118, the exhalation flow path 110 may exit theOPEP device 100 through at least one of the first chamber outlet 106 andthe second chamber outlet 108. In this way, the exhalation flow path 110is “folded” upon itself, i.e., it reverses longitudinal directionsbetween the chamber inlet 104 and one of the first chamber outlet 106 orthe second chamber outlet 108. However, those skilled in the art willappreciate that the exhalation flow path 110 identified by the dashedline is exemplary, and that air exhaled into the OPEP device 100 mayflow in any number of directions or paths as it traverses from themouthpiece 109 or chamber inlet 104 and the first chamber outlet 106 orthe second chamber outlet 108.

FIG. 3 also shows various other features of the OPEP device 100associated with the housing 102. For example, a stop 122 prevents arestrictor member 130 (see FIG. 5), described below, from opening in awrong direction; a seat 124 shaped to accommodate the restrictor member130 is formed about the chamber inlet 104; and, an upper bearing 126 anda lower bearing 128 are formed within the housing 102 and configured toaccommodate a shaft rotatably mounted therebetween. One or more guidewalls 120 are positioned in the second chamber 118 to direct exhaled airalong the exhalation flow path 110.

Turning to FIGS. 5-7, various cross-sectional perspective views of theOPEP device 100 are shown with its internal components. The internalcomponents of the OPEP device 100 comprise a restrictor member 130, avane 132, and an optional variable nozzle136. As shown, the restrictormember 130 and the vane 132 are operatively connected by means of ashaft 134 rotatably mounted between the upper bearing 126 and the lowerbearing 128, such that the restrictor member 130 and the vane 132 arerotatable in unison about the shaft 134. As described below in furtherdetail, the variable nozzle 136 includes an orifice 138 configured toincrease in size in response to the flow of exhaled air therethrough.

FIGS. 4-6 further illustrate the division of the first chamber 114 andthe second chamber 118 within the housing 102. As previously described,the chamber inlet 104 defines an entrance to the first chamber 114. Therestrictor member 130 is positioned in the first chamber 114 relative toa seat 124 about the chamber inlet 104 such that it is moveable betweena closed position, where a flow of exhaled air along the exhalation flowpath 110 through the chamber inlet 104 is restricted, and an openposition, where the flow of exhaled air through the chamber inlet 104 isless restricted. Likewise, the variable nozzle 136, which is optional,is mounted about or positioned in the chamber passage 116, such that theflow of exhaled air entering the first chamber 114 exits the firstchamber 114 through the orifice 138 of the variable nozzle 136. Exhaledair exiting the first chamber 114 through the orifice 138 of thevariable nozzle 136 enters the second chamber, which is defined by thespace within the housing 102 occupied by the vane 132 and the guidewalls 120. Depending on the position of the vane 132, the exhaled air isthen able to exit the second chamber 118 through at least one of thefirst chamber outlet 106 and the second chamber outlet 108.

FIGS. 8-14 show the internal components of the OPEP device 100 ingreater detail. Turning first to FIGS. 8-9, a front perspective view anda rear perspective view shows the restrictor member 130 operativelyconnected to the vane 132 by the shaft 134. As such, the restrictormember 130 and the vane 132 are rotatable about the shaft 134 such thatrotation of the restrictor member 130 results in a correspondingrotation of the vane 132, and vice-versa. Like the housing 102, therestrictor member 130 and the vane 132 may be made of constructed of anydurable material, such as a polymer. Preferably, they are constructed ofa low shrink, low friction plastic. One such material is acetal.

As shown, the restrictor member 130, the vane 132, and the shaft 134 areformed as a unitary component. The restrictor member 130 is generallydisk-shaped, and the vane 132 is planar. The restrictor member 130includes a generally circular face 140 axially offset from the shaft 134and a beveled or chamfered edge 142 shaped to engage the seat 124 formedabout the chamber inlet 104. In this way, the restrictor member 130 isadapted to move relative to the chamber inlet 104 about an axis ofrotation defined by the shaft 134 such that the restrictor member 130may engage the seat 124 in a closed position to substantially seal andrestrict the flow of exhaled air through the chamber inlet 104. However,it is envisioned that the restrictor member 130 and the vane 132 may beformed as separate components connectable by any suitable means suchthat they remain independently replaceable with a restrictor member 130or a vane132 of a different shape, size, or weight, as selected tomaintain ideal operating conditions. For example, the restrictor member130 and/or the vane 132 may include one or more contoured surfaces.Alternatively, the restrictor member 130 may be configured as abutterfly valve.

Turning to FIG. 10, a front view of the restrictor member 130 and thevane 132 is shown. As previously described, the restrictor member 130comprises a generally circular face 140 axially offset from the shaft134. The restrictor member 130 further comprises a second offsetdesigned to facilitate movement of the restrictor member 130 between aclosed position and an open position. More specifically, a center 144 ofthe face 140 of the restrictor member 130 is offset from the planedefined by the radial offset and the shaft 134, or the axis of rotation.In other words, a greater surface area of the face 140 of the restrictormember 130 is positioned on one side of the shaft 134 than on the otherside of the shaft 134. Pressure at the chamber inlet 104 derived fromexhaled air produces a force acting on the face 140 of the restrictormember 130. Because the center 144 of the face 140 of the restrictormember 130 is offset as described above, a resulting force differentialcreates a torque about the shaft 134. As further explained below, thistorque facilitates movement of the restrictor member 130 between aclosed position and an open position.

Turning to FIG. 11, a top view of the restrictor member 130 and the vane132 is shown. As illustrated, the vane 132 is connected to the shaft 134at a 75° angle relative to the face 140 of restrictor member 130.Preferably, the angle will remain between 60° and 80°, although it isenvisioned that the angle of the vane 132 may be selectively adjusted tomaintain the ideal operating conditions, as previously discussed. It isalso preferable that the vane 132 and the restrictor member 130 areconfigured such that when the OPEP device 100 is fully assembled, theangle between a centerline of the variable nozzle 136 and the vane 132is between 10° and 25° when the restrictor member 130 is in a closedposition. Moreover, regardless of the configuration, it is preferablethat the combination of the restrictor member 130 and the vane 132 havea center of gravity aligned with the shaft 134, or the axis of rotation.In full view of the present disclosure, it should be apparent to thoseskilled in the art that the angle of the vane 132 may be limited by thesize or shape of the housing 102, and will generally be less than halfthe total rotation of the vane 132 and the restrictor member 130.

Turning to FIGS. 12 and 13, a front perspective view and a rearperspective view of the variable nozzle 136 is shown without the flow ofexhaled air therethrough. In general, the variable nozzle 136 includestop and bottom walls 146, side walls 148, and V-shaped slits 150 formedtherebetween. As shown, the variable nozzle is generally shaped like aduck-bill type valve. However, it should be appreciated that nozzles orvalves of other shapes and sizes may also be used. The variable nozzle136 may also include a lip 152 configured to mount the variable nozzle136 within the housing 102 between the first chamber 114 and the secondchamber 118. The variable nozzle 136 may be constructed or molded of anymaterial having a suitable flexibility, such as silicone, and preferablywith a wall thickness of between 0.50 and 2.00 millimeters, and anorifice width between 0.25 to 1.00 millimeters, or smaller depending onmanufacturing capabilities.

As previously described, the variable nozzle 136 is optional in theoperation of the OPEP device 100. It should also be appreciated that theOPEP device 100 could alternatively omit both the chamber passage 116and the variable nozzle 136, and thus comprise a single-chamberembodiment. Although functional without the variable nozzle 136, theperformance of the OPEP device 100 over a wider range of exhalation flowrates is improved when the OPEP device 100 is operated with the variablenozzle 136. The chamber passage 116, when used without the variablenozzle 136, or the orifice 138 of the variable nozzle 136, when thevariable nozzle 136 is included, serves to create a jet of exhaled airhaving an increased velocity. As explained in more detail below, theincreased velocity of the exhaled air entering the second chamber 118results in a proportional increase in the force applied by the exhaledair to the vane 132, and in turn, an increased torque about the shaft134, all of which affect the ideal operating conditions.

Without the variable nozzle 136, the orifice between the first chamber114 and the second chamber 118 is fixed according to the size, shape,and cross-sectional area of the chamber passage 116, which may beselectively adjusted by any suitable means, such as replacement of themiddle section 103 or the rear section 105 of the housing. On the otherhand, when the variable nozzle 136 is included in the OPEP device 100,the orifice between the first chamber 114 and the second chamber 118 isdefined by the size, shape, and cross-sectional area of the orifice 138of the variable nozzle 136, which may vary according to the flow rate ofexhaled air and/or the pressure in the first chamber 114.

Turning to FIG. 14, a front perspective view of the variable nozzle 136is shown with a flow of exhaled air therethrough. One aspect of thevariable nozzle 136 shown in FIG. 14 is that, as the orifice 138 opensin response to the flow of exhaled air therethrough, the cross-sectionalshape of the orifice 138 remains generally rectangular, which during theadministration of OPEP therapy results in a lower drop in pressurethrough the variable nozzle 136 from the first chamber 114 (See FIGS. 3and 5) to the second chamber 118. The generally consistent rectangularshape of the orifice 138 of the variable nozzle 136 during increasedflow rates is achieved by the V-shaped slits 150 formed between the topand bottom walls 146 and the side walls 148, which serve to permit theside walls 148 to flex without restriction. Preferably, the V-shapedslits 150 are as thin as possible to minimize the leakage of exhaled airtherethrough. For example, the V-shaped slits 150 may be approximately0.25 millimeters wide, but depending on manufacturing capabilities,could range between 0.10 and 0.50 millimeters. Exhaled air that doesleak through the V-shaped slits 150 is ultimately directed along theexhalation flow path by the guide walls 120 in the second chamber 118protruding from the housing 102.

It should be appreciated that numerous factors contribute to the impactthe variable nozzle 136 has on the performance of the OPEP device 100,including the geometry and material of the variable nozzle 136. By wayof example only, in order to attain a target oscillating pressurefrequency of between 10 to 13 Hz at an exhalation flow rate of 15 litersper minute, in one embodiment, a 1.0 by 20.0 millimeter passage ororifice may be utilized. However, as the exhalation flow rate increases,the frequency of the oscillating pressure in that embodiment alsoincreases, though at a rate too quickly in comparison to the targetfrequency. In order to attain a target oscillating pressure frequency ofbetween 18 to 20 Hz at an exhalation flow rate of 45 liters per minute,the same embodiment may utilize a 3.0 by 20.0 millimeter passage ororifice. Such a relationship demonstrates the desirability of a passageor orifice that expands in cross-sectional area as the exhalation flowrate increases in order to limit the drop in pressure across thevariable nozzle 136.

Turning to FIGS. 15A-C, top phantom views of the OPEP device 100 show anexemplary illustration of the operation of the OPEP device 100.Specifically, FIG. 15A shows the restrictor member 130 in an initial, orclosed position, where the flow of exhaled air through the chamber inlet104 is restricted, and the vane 132 is in a first position, directingthe flow of exhaled air toward the first chamber outlet 106. FIG. 15Bshows this restrictor member 130 in a partially open position, where theflow of exhaled air through the chamber inlet 104 is less restricted,and the vane 132 is directly aligned with the jet of exhaled air exitingthe variable nozzle 136. FIG. 15C shows the restrictor member 130 in anopen position, where the flow of exhaled air through the chamber inlet104 is even less restricted, and the vane 132 is in a second position,directing the flow of exhaled air toward the second chamber outlet 108.It should be appreciated that the cycle described below is merelyexemplary of the operation of the OPEP device 100, and that numerousfactors may affect operation of the OPEP device 100 in a manner thatresults in a deviation from the described cycle. However, during theoperation of the OPEP device 100, the restrictor member 130 and the vane132 will generally reciprocate between the positions shown in FIGS. 15Aand 15C.

During the administration of OPEP therapy, the restrictor member 130 andthe vane 132 may be initially positioned as shown in FIG. 15A. In thisposition, the restrictor member 130 is in a closed position, where theflow of exhaled air along the exhalation path through the chamber inlet104 is substantially restricted. As such, an exhalation pressure at thechamber inlet 104 begins to increase when a user exhales into themouthpiece 108. As the exhalation pressure at the chamber inlet 104increases, a corresponding force acting on the face 140 of therestrictor member 130 increases. As previously explained, because thecenter 144 of the face 140 is offset from the plane defined by theradial offset and the shaft 134, a resulting net force creates anegative or opening torque about the shaft. In turn, the opening torquebiases the restrictor member 130 to rotate open, letting exhaled airenter the first chamber 114, and biases the vane 132 away from its firstposition. As the restrictor member 130 opens and exhaled air is let intothe first chamber 114, the pressure at the chamber inlet 104 begins todecrease, the force acting on the face 140 of the restrictor memberbegins to decrease, and the torque biasing the restrictor member 130open begins to decrease.

As exhaled air continues to enter the first chamber 114 through thechamber inlet 104, it is directed along the exhalation flow path 110 bythe housing 102 until it reaches the chamber passage 116 disposedbetween the first chamber 114 and the second chamber 118. If the OPEPdevice 100 is being operated without the variable nozzle 136, theexhaled air accelerates through the chamber passage 116 due to thedecrease in cross-sectional area to form a jet of exhaled air. Likewise,if the OPEP device 100 is being operated with the variable nozzle 136,the exhaled air accelerates through the orifice 138 of the variablenozzle 136, where the pressure through the orifice 138 causes the sidewalls 148 of the variable nozzle 136 to flex outward, thereby increasingthe size of the orifice 138, as well as the resulting flow of exhaledair therethrough. To the extent some exhaled air leaks out of theV-shaped slits 150 of the variable nozzle 136, it is directed backtoward the jet of exhaled air and along the exhalation flow path by theguide walls 120 protruding into the housing 102.

Then, as the exhaled air exits the first chamber 114 through thevariable nozzle 136 and/or chamber passage 116 and enters the secondchamber 118, it is directed by the vane 132 toward the front section 101of the housing 102, where it is forced to reverse directions beforeexiting the OPEP device 100 through the open first chamber exit 106. Asa result of the change in direction of the exhaled air toward the frontsection 101 of the housing 102, a pressure accumulates in the secondchamber 118 near the front section 101 of the housing 102, therebyresulting in a force on the adjacent vane 132, and creating anadditional negative or opening torque about the shaft 134. The combinedopening torques created about the shaft 134 from the forces acting onthe face 140 of the restrictor member 130 and the vane 132 cause therestrictor member 130 and the vane 132 to rotate about the shaft 134from the position shown in FIG. 15A toward the position shown in FIG.15B.

When the restrictor member 130 and the vane 132 rotate to the positionshown in FIG. 15B, the vane 132 crosses the jet of exhaled air exitingthe variable nozzle 136 or the chamber passage 116. Initially, the jetof exhaled air exiting the variable nozzle 136 or chamber passage 116provides a force on the vane 132 that, along with the momentum of thevane 132, the shaft 134, and the restrictor member 130, propels the vane132 and the restrictor member 130 to the position shown in FIG. 15C.However, around the position shown in FIG. 15B, the force acting on thevane 132 from the exhaled air exiting the variable nozzle 136 alsoswitches from a negative or opening torque to a positive or closingtorque. More specifically, as the exhaled air exits the first chamber114 through the variable nozzle 136 and enters the second chamber 118,it is directed by the vane 132 toward the front section 101 of thehousing 102, where it is forced to reverse directions before exiting theOPEP device 100 through the open second chamber exit 108. As a result ofthe change in direction of the exhaled air toward the front section 101of the housing 102, a pressure accumulates in the second chamber 118near the front section 101 of the housing 102, thereby resulting in aforce on the adjacent vane 132, and creating a positive or closingtorque about the shaft 134. As the vane 132 and the restrictor member130 continue to move closer to the position shown in FIG. 15C, thepressure accumulating in the section chamber 118 near the front section101 of the housing 102, and in turn, the positive or closing torqueabout the shaft 134, continues to increase, as the flow of exhaled airalong the exhalation flow path 110 and through the chamber inlet 104 iseven less restricted. Meanwhile, although the torque about the shaft 134from the force acting on the restrictor member 130 also switches from anegative or opening torque to a positive or closing torque around theposition shown in FIG. 15B, its magnitude is essentially negligible asthe restrictor member 130 and the vane 132 rotate from the positionshown in FIG. 15B to the position shown in FIG. 15C.

After reaching the position shown in FIG. 15C, and due to the increasedpositive or closing torque about the shaft 134, the vane 132 and therestrictor member 130 reverse directions and begin to rotate back towardthe position shown in FIG. 15B. As the vane 132 and the restrictormember 130 approach the position shown in FIG. 15B, and the flow ofexhaled through the chamber inlet 104 is increasingly restricted, thepositive or closing torque about the shaft 134 begins to decrease. Whenthe restrictor member 130 and the vane 132 reach the position 130 shownin FIG. 15B, the vane 132 crosses the jet of exhaled air exiting thevariable nozzle 136 or the chamber passage 116, thereby creating a forceon the vane 132 that, along with the momentum of the vane 132, the shaft134, and the restrictor member 130, propels the vane 132 and therestrictor member 130 back to the position shown in FIG. 15A. After therestrictor member 130 and the vane 132 return to the position shown inFIG. 15A, the flow of exhaled air through the chamber inlet 104 isrestricted, and the cycle described above repeats itself.

It should be appreciated that, during a single period of exhalation, thecycle described above will repeat numerous times. Thus, by repeatedlymoving the restrictor member 130 between a closed position, where theflow of exhaled air through the chamber inlet 104 is restricted, and anopen position, where the flow of exhaled air through the chamber inlet104 is less restricted, an oscillating back pressure is transmitted tothe user of the OPEP device 100 and OPEP therapy is administered.

Turning now to FIGS. 16-17, an alternative embodiment of a variablenozzle 236 is shown. The variable nozzle 236 may be used in the OPEPdevice 100 as an alternative to the variable nozzle 136 described above.As shown in FIGS. 16-17, the variable nozzle 236 includes an orifice238, top and bottom walls 246, side walls 248, and a lip 252 configuredto mount the variable nozzle 236 within the housing of the OPEP device100 between the first chamber 114 and the second chamber 118 in the samemanner as the variable nozzle 136. Similar to the variable nozzle 136shown in FIGS. 12-13, the variable nozzle 236 may be constructed ormolded of any material having a suitable flexibility, such as silicone.

During the administration of OPEP therapy, as the orifice 238 of thevariable nozzle 236 opens in response to the flow of exhaled airtherethrough, the cross-sectional shape of the orifice 238 remainsgenerally rectangular, which results in a lower drop in pressure throughthe variable nozzle 236 from the first chamber 114 to the second chamber118. The generally consistent rectangular shape of the orifice 238 ofthe variable nozzle 236 during increased flow rates is achieved by thin,creased walls formed in the top and bottom walls 246, which allow theside walls 248 to flex easier and with less resistance. A furtheradvantage of this embodiment is that there is no leakage out of the topand bottom walls 246 while exhaled air flows through the orifice 238 ofthe variable nozzle 236, such as for example, through the V-shaped slits150 of the variable nozzle 136 shown in FIGS. 12-13.

Those skilled in the art will also appreciate that, in someapplications, only positive expiratory pressure (without oscillation)may be desired, in which case the OPEP device 100 may be operatedwithout the restrictor member 130, but with a fixed orifice or manuallyadjustable orifice instead. The positive expiratory pressure embodimentmay also comprise the variable nozzle 136, or the variable nozzle 236,in order to maintain a relatively consistent back pressure within adesired range.

Second Embodiment

Turning now to FIGS. 18-19, a front perspective view and a rearperspective view of a second embodiment of an OPEP device 200 is shown.The configuration and operation of the OPEP device 200 is similar tothat of the OPEP device 100. However, as best shown in FIGS. 20-24, theOPEP device 200 further includes an adjustment mechanism 253 adapted tochange the relative position of the chamber inlet 204 with respect tothe housing 202 and the restrictor member 230, which in turn changes therange of rotation of the vane 232 operatively connected thereto. Asexplained below, a user is therefore able to conveniently adjust boththe frequency and the amplitude of the OPEP therapy administered by theOPEP device 200 without opening the housing 202 and disassembling thecomponents of the OPEP device 200.

The OPEP device 200 generally comprises a housing 202, a chamber inlet204, a first chamber outlet 206 (best seen in FIGS. 23 and 32), a secondchamber outlet 208 (best seen in FIGS. 23 and 32), and a mouthpiece 209in fluid communication with the chamber inlet 204. As with the OPEPdevice 100, a front section 201, a middle section 203, and a rearsection 205 of the housing 202 are separable so that the componentscontained therein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions.The OPEP device also includes an adjustment dial 254, as describedbelow.

As discussed above in relation to the OPEP device 100, the OPEP device200 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 200 isequipped with an inhalation port 211 (best seen in FIGS. 19, 21, and 23)in fluid communication with the mouthpiece 209 and the chamber inlet204. As noted above, the inhalation port may include a separate one-wayvalve (not shown) to permit a user of the OPEP device 200 both to inhalethe surrounding air through the one-way valve and to exhale through thechamber inlet 204 without withdrawing the mouthpiece 209 of the OPEPdevice 200 between periods of inhalation and exhalation. In addition,the aforementioned aerosol delivery devices may be connected to theinhalation port 211 for the simultaneous administration of aerosol andOPEP therapies.

An exploded view of the OPEP device 200 is shown in FIG. 20. In additionto the components of the housing described above, the OPEP device 200includes a restrictor member 230 operatively connected to a vane 232 bya pin 231, an adjustment mechanism 253, and a variable nozzle 236. Asshown in the cross-sectional view of FIG. 21, when the OPEP device 200is in use, the variable nozzle 236 is positioned between the middlesection 203 and the rear section 205 of the housting 202, and theadjustment mechanism 253, the restrictor member 230, and the vane 232form an assembly.

Turning to FIGS. 21-23, various cross-sectional perspective views of theOPEP device 200 are shown. As with the OPEP device 100, an exhalationflow path 210, identified by a dashed line, is defined between themouthpiece 209 and at least one of the first chamber outlet 206 and thesecond chamber outlet 208 (best seen in FIGS. 23 and 32). As a result ofa one-way valve (not-shown) and/or an aerosol delivery device (notshown) attached to the inhalation port 211, the exhalation flow path 210begins at the mouthpiece 209 and is directed toward the chamber inlet204, which in operation may or may not be blocked by the restrictormember 230. After passing through the chamber inlet 204, the exhalationflow path 210 enters a first chamber 214 and makes a 180° turn towardthe variable nozzle 236. After passing through the orifice 238 of thevariable nozzle 236, the exhalation flow path 210 enters a secondchamber 218. In the second chamber 218, the exhalation flow path 210 mayexit the OPEP device 200 through at least one of the first chamberoutlet 206 or the second chamber outlet 208. Those skilled in the artwill appreciate that the exhalation flow path 210 identified by thedashed line is exemplary, and that air exhaled into the OPEP device 200may flow in any number of directions or paths as it traverses from themouthpiece 209 or chamber inlet 204 to the first chamber outlet 206 orthe second chamber outlet 208.

Referring to FIGS. 24-25, front and rear perspective views of theadjustment mechanism 253 of the OPEP device 200 are shown. In general,the adjustment mechanism 253 includes an adjustment dial 254, a shaft255, and a frame 256. A protrusion 258 is positioned on a rear face 260of the adjustment dial, and is adapted to limit the selective rotationof the adjustment mechanism 253 by a user, as further described below.The shaft 255 includes keyed portions 262 adapted to fit within upperand lower bearings 226, 228 formed in the housting 200 (see FIGS. 21 and28-29). The shaft further includes an axial bore 264 configured toreceive the pin 231 operatively connecting the restrictor member 230 andthe vane 232. As shown, the frame 256 is spherical, and as explainedbelow, is configured to rotate relative to the housting 202, whileforming a seal between the housting 202 and the frame 256 sufficient topermit the administration of OPEP therapy. The frame 256 includes acircular opening defined by a seat 224 adapted to accommodate therestrictor member 230. In use, the circular opening functions as thechamber inlet 204. The frame 256 also includes a stop 222 for preventingthe restrictor member 230 from opening in a wrong direction.

Turning to FIG. 26, a front perspective view of the restrictor member230 and the vane 232 is shown. The design, materials, and configurationof the restrictor member 230 and the vane 232 may be the same asdescribed above in regards to the OPEP device 100. However, therestrictor member 230 and the vane 232 in the OPEP device 200 areoperatively connected by a pin 231 adapted for insertion through theaxial bore 264 in the shaft 255 of the adjustment mechanism 253. The pin231 may be constructed, for example, by stainless steel. In this way,rotation of the restrictor member 230 results in a correspondingrotation of the vane 232, and vice versa.

Turning to FIG. 27, a front perspective view of the adjustment mechanism253 assembled with the restrictor member 230 and the vane 232 is shown.In this configuration, it can be seen that the restrictor member 230 ispositioned such that it is rotatable relative to the frame 256 and theseat 224 between a closed position (as shown), where a flow of exhaledair along the exhalation flow path 210 through the chamber inlet 204 isrestricted, and an open position (not shown), where the flow of exhaledair through the chamber inlet 204 is less restricted. As previouslymentioned the vane 232 is operatively connected to the restrictor member230 by the pin 231 extending through shaft 255, and is adapted to movein unison with the restrictor member 230. It can further be seen thatthe restrictor member 230 and the vane 232 are supported by theadjustment mechanism 253, which itself is rotatable within the housting202 of the OPEP device 200, as explained below.

FIGS. 28 and 29A-B are partial cross-sectional views illustrating theadjustment mechanism 253 mounted within the housting 202 of the OPEPdevice 200. As shown in FIG. 28, the adjustment mechanism 253, as wellas the restrictor member 230 and the vane 232, are rotatably mountedwithin the housting 200 about an upper and lower bearing 226, 228, suchthat a user is able to rotate the adjustment mechanism 253 using theadjustment dial 254. FIGS. 29A-29B further illustrates the process ofmounting and locking the adjustment mechanism 253 within the lowerbearing 228 of the housting 202. More specifically, the keyed portion262 of the shaft 255 is aligned with and inserted through a rotationallock 166 formed in the housting 202, as shown in FIG. 29A. Once thekeyed portion 262 of the shaft 255 is inserted through the rotationallock 266, the shaft 255 is rotated 90° to a locked position, but remainsfree to rotate. The adjustment mechanism 253 is mounted and lockedwithin the upper bearing 226 in the same manner.

Once the housting 200 and the internal components of the OPEP device 200are assembled, the rotation of the shaft 255 is restricted to keep itwithin a locked position in the rotational lock 166. As shown in a frontview of the OPEP device 200 in FIG. 30, two stops 268, 288 arepositioned on the housting 202 such that they engage the protrusion 258formed on the rear face 260 of the adjustment dial 254 when a userrotates the adjustment dial 254 to a predetermined position. Forpurposes of illustration, the OPEP device 200 is shown in FIG. 30without the adjustment dial 254 or the adjustment mechanism 253, whichwould extend from the housting 202 through an opening 269. In this way,rotation of the adjustment dial 254, the adjustment mechanism 253, andthe keyed portion 262 of the shaft 255 can be appropriately restricted.

Turning to FIG. 31, a partial cross-sectional view of the adjustmentmechanism 253 mounted within the housting 200 is shown. As previouslymentioned, the frame 256 of the adjustment mechanism 253 is spherical,and is configured to rotate relative to the housting 202, while forminga seal between the housting 202 and the frame 256 sufficient to permitthe administration of OPEP therapy. As shown in FIG. 31, a flexiblecylinder 271 extending from the housing 202 completely surrounds aportion of the frame 256 to form a sealing edge 270. Like the housting202 and the restrictor member 230, the flexible cylinder 271 and theframe 256 may be constructed of a low shrink, low friction plastic. Onesuch material is acetal. In this way, the sealing edge 270 contacts theframe 256 for a full 360° and forms a seal throughout the permissiblerotation of the adjustment member 253

The selective adjustment of the OPEP device 200 will now be describedwith reference to FIGS. 32A-B, 33A-B, and 34A-B. FIGS. 32A-B are partialcross-sectional views of the OPEP device 200; FIGS. 33A-B areillustrations of the adjustability of the OPEP device 200; and, FIGS.34A-B are top phantom views of the OPEP device 200. As previouslymentioned with regards to the OPEP device 100, it is preferable that thevane 232 and the restrictor member 230 are configured such that when theOPEP device 200 is fully assembled, the angle between a centerline ofthe variable nozzle 236 and the vane 232 is between 10° and 25° when therestrictor member 230 is in a closed position. However, it should beappreciated that the adjustability of the OPEP device 200 is not limitedto the parameters described herein, and that any number ofconfigurations may be selected for purposes of administering OPEPtherapy within the ideal operating conditions.

FIG. 32A shows the vane 232 at an angle of 10° from the centerline ofthe variable nozzle 236, whereas FIG. 32B shows the vane 232 at an angleof 25° from the centerline of the variable nozzle 236. FIG. 33Aillustrates the necessary position of the frame 256 (shown in phantom)relative to the variable nozzle 236 such that the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 33B, on the otherhand, illustrates the necessary position of the frame 256 (shown inphantom) relative to the variable nozzle 236 such that the angle betweena centerline of the variable nozzle 236 and the vane 232 is 25° when therestrictor member 230 is in the closed position.

Referring to FIGS. 34A-B, side phantom views of the OPEP device 200 areshown. The configuration shown in FIG. 34A corresponds to theillustrations shown in FIGS. 32A and 33A, wherein the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 34B, on the otherhand, corresponds to the illustrations shown in FIGS. 32B and 33B,wherein the angle between a centerline of the variable nozzle 236 andthe vane 232 is 25° when the restrictor member 230 is in the closedposition. In other words, the frame 256 of the adjustment member 253 hasbeen rotated counter-clockwise 15°, from the position shown in FIG. 34A,to the position shown in FIG. 34B, thereby also increasing thepermissible rotation of the vane 232.

In this way, a user is able to rotate the adjustment dial 254 toselectively adjust the orientation of the chamber inlet 204 relative tothe restrictor member 230 and the housting 202. For example, a user mayincrease the frequency and amplitude of the OPEP therapy administered bythe OPEP device 200 by rotating the adjustment dial 254, and thereforethe frame 256, toward the position shown in FIG. 34A. Alternatively, auser may decrease the frequency and amplitude of the OPEP therapyadministered by the OPEP device 200 by rotating the adjustment dial 254,and therefore the frame 256, toward the position shown in FIG. 34B.Furthermore, as shown for example in FIGS. 18 and 30, indicia may beprovided to aid the user in the setting of the appropriate configurationof the OPEP device 200.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 200.

Third Embodiment

Turning now to FIGS. 35-38, a third embodiment of an OPEP device 300 isshown. As described below, with the exception of an adjustment mechanism353, the design and operation of the OPEP device 300 is the same as theOPEP device 200. For example, as seen in the front perspective view ofFIG. 35, a housing 302 of the OPEP device 300 includes a mouthpiece 309,a first chamber outlet 306, and a second chamber outlet (not shown)positioned opposite the first chamber outlet 306. The housing 302 isformed of a front section 301, a middle section 303, and a rear section305. As shown in the cross-sectional view of FIG. 36, the OPEP device300 also includes a restrictor member 330 operatively connected to avane 332 by a shaft (not shown), and a variable nozzle 336 separating afirst chamber 314 and a second chamber 318. Finally, an exhalation flowpath 310, identified by a dashed line, is formed between the mouthpiece309 and at least one of the first chamber outlet 306 and the secondchamber outlet. Those skilled in the art will appreciate that theexhalation flow path 310 identified by the dashed line is exemplary, andthat air exhaled into the OPEP device 300 may flow in any number ofdirections or paths as it traverses from the mouthpiece 309 or chamberinlet 304 to the first chamber outlet 306 or the second chamber outlet.

Referring to FIGS. 37-38, a front perspective view and a rearperspective view of the adjustment mechanism 353 assembled with therestrictor member 330 and the vane 332 are shown. The adjustmentmechanism 353 is comprised of a cup 372 shaped to fit within the housing302 such that a user may rotate the cup 372 relative to the housing 302via an adjustment dial 354. A wall 374 extends through the centralportion of the cup 372. The wall 372 includes an opening defined by aseat 324 shaped to accommodate the restrictor member 330. As seen inFIG. 36, the opening operates as the chamber inlet 304 during theadministration of OPEP therapy. The cup 372 further includes an upperbearing 326 and a lower bearing 328 adapted to rotatably mount therestrictor member 330, the vane 332, and the shaft (not shown) to theadjustment mechanism 353, such that the restrictor member 330 and thevane 332 are rotatable relative to the cup 372. The wall also includes astop 322 to prevent the restrictor member 330 from opening in a wrongdirection.

When the OPEP device 300 is fully assembled as shown in FIGS. 35-36, auser is able to rotate the adjustment dial 354 relative to the housing302 to selectively adjust the frequency and amplitude of the OPEPtherapy administered by the OPEP device 300. Similar to the adjustmentmechanism 253 of the OPEP device 200, a user may adjust the orientationof the chamber inlet 304 relative to the restrictor member 330 in theOPEP device 300 by rotating the adjustment dial 354, thereby rotatingthe cup 372 and the wall 374 relative to the restrictor member 330 andthe housing 302. A user may increase the frequency and amplitude of theOPEP therapy administered by the OPEP device 300 by rotating theadjustment dial 354, and therefore the wall 374, in the clockwisedirection. Alternatively, a user may decrease the frequency andamplitude of the OPEP therapy administered by the OPEP device 300 byrotating the adjustment dial 354, and therefore the wall 374, in thecounter-clockwise direction. As shown in FIGS. 35-36, a protrusion 358extending from the housing 302 through a slot 376 in the adjustment dial354 may be provided to restrict the rotation of the adjustment dial 354such that the permissible configurations of the OPEP device 300 arelimited, and the ideal operating conditions are maintained.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 300.

Fourth Embodiment

Turning to FIGS. 39-40, a fourth embodiment of an OPEP device 400 isshown. Although the configuration of the OPEP device 400 differs fromthat of the OPEP device 300 and the OPEP device 200, the internalcomponents and operation of the OPEP device 400 are otherwise the same.For example, as seen in the front perspective view of FIG. 39, a housing402 of the OPEP device 400 includes a mouthpiece 409, a first chamberoutlet 406, and a second chamber outlet 408 (best seen in FIGS. 41A-41B) positioned opposite the first chamber outlet. The housing 402 isformed of a front section 401, a middle section 403, and a rear section405, as well as an upper section 407 adapted to rotate relative to thefront section 401, the middle section 403, and the rear section 405.

As seen in the cross-sectional view of FIG. 40, the OPEP device 400further includes a restrictor member 430 operatively connected to a vane432 by a shaft (not shown), and a variable nozzle 436 separating a firstchamber 414 and a second chamber 418. The upper section 407 of thehousing 402 includes a frame 456 having a seat 424 shaped to accommodatethe restrictor member 430, a stop 422 to prevent the restrictor member430 from opening in a wrong direction, as well as an upper bearing 426and a lower bearing 428 about which the shaft (not shown) operativelyconnecting the restrictor member 430 and the vane 436 is rotatablymounted. In operation, the seat 422 defines the chamber inlet 404.Consequently, the restrictor member 430 is rotatable relative to theseat 422 and the chamber inlet 404.

As with the previously described embodiments, an exhalation flow path410, identified by a dashed line, is formed between the mouthpiece 409and at least one of the first chamber outlet 406 and the second chamberoutlet 408. Once again, those skilled in the art will appreciate thatthe exhalation flow path 410 identified by the dashed line is exemplary,and that air exhaled into the OPEP device 400 may flow in any number ofdirections or paths as it traverses from the mouthpiece 409 or chamberinlet 404 to the first chamber outlet 406 or the second chamber outlet408. Due to the configuration of the OPEP device 400, the exhalationflow path 410 differs from those of the embodiments described above.More specifically, the exhalation flow path 410 begins at the mouthpiece409 formed in the upper section 407 of the housing 402, passes throughthe chamber inlet 404, and enters into a first chamber 114. In the firstchamber 414, the exhalation flow path makes a 180° turn in the directionof the front section 401 of the housing 402, followed by a 90° turntoward the bottom of the OPEP device 400, past a second chamber 418 ofthe housing 402. The exhalation flow path 410 then makes a 90° turntoward the rear section 405 of the housing 402, where it makes another180° turn and passes through a variable nozzle 436, and enters into thesecond chamber 418. In the second chamber 418, the exhalation flow path410 may exit the OPEP device 410 through at least one of the firstchamber outlet 406 or the second chamber outlet 408.

As seen in FIGS. 40 and 41A-B, the upper section 407 of the housing 402is rotatable relative to the front section 401, the middle section 403,and the rear section 405 of the housing 402. In this way, a user is ableto rotate the upper section 407 relative to the front section 401, themiddle section 403, and the rear section 405 to selectively adjust theorientation of the chamber inlet 404 relative to the restrictor member430 and the housing 402, and thereby selectively adjust the frequencyand amplitude of the OPEP therapy administered by the OPEP device 400,in a similar manner as previously described in relation to theadjustability of the OPEP device 200. For example, a user may increasethe frequency and amplitude of the OPEP therapy administered by the OPEPdevice 400 by rotating the upper section 407, and therefore the seat422, relative to the front section 401, the middle section 403, and therear section 405, toward the position shown in FIG. 41A. Alternatively,a user may decrease the frequency and amplitude of the OPEP therapyadministered by the OPEP device 400 by rotating the upper section 407,and therefore the seat 422, relative to the front section 401, themiddle section 403, and the rear section 405, toward the position shownin FIG. 41 B. Furthermore, as shown in FIGS. 40 and 41A-B, a protrusion458 extending from the middle section 403 of the housing 402 may beprovided to restrict the rotation of the upper section 407 such that thepermissible configurations of the OPEP device 400 are limited, and theideal operating conditions are maintained.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 400.

Turning to FIGS. 42-47, various alternative embodiments of the OPEPdevice 100 are shown. Although the embodiments shown in FIGS. 42-47 anddescribed below are alternative embodiments of the OPEP device 100, itshould be appreciated that the disclosed modifications may be applied toany of the embodiments described herein.

Fifth Embodiment

Referring to FIGS. 42-43, an OPEP device 500 is shown having a chamberinlet bypass 578 adapted to permit exhaled air into a first chamber 514without passing through the chamber inlet 504. With the exception of thechamber inlet bypass 578, the OPEP device 500 is otherwise configuredand operates the same as the OPEP device 100. As shown, the OPEP device500 includes a housing 502 comprising a front section 501, a middlesection 503, and a rear section 505. The housing is also associated witha mouthpiece 509, and includes a first chamber outlet 506 and a secondchamber outlet (not shown) opposite the first chamber outlet 506. Asseen in the cross-sectional view of the FIG. 43, the OPEP device 500includes a restrictor member 530 positioned relative to a seat 524 aboutthe chamber inlet 504 such that it is moveable between a closedposition, where the flow of exhaled air through the chamber inlet 504 isrestricted, and an open position, where the flow of exhaled air throughthe chamber inlet 504 is less restricted. The OPEP device 500 furtherincludes a chamber inlet bypass 578 that allows a small amount ofexhaled air to move past the chamber inlet 504 and the restrictor member530 at all times. An exemplary flow path 577 through the chamber inletbypass 578 is identified in FIG. 43 by a dashed line. By permitting asmall amount of exhaled air to bypass the chamber inlet 504 and therestrictor member 530 through the chamber inlet bypass 578, theamplitude of the OPEP therapy administered by the OPEP device 500 isdecreased, while the frequency remains substantially unaffected.

Furthermore, a regulation member 579 extending from the mouthpiece 509permits a user to selectively adjust the amount of exhaled air allowedto flow through the chamber inlet bypass 578. For example, as shown inFIG. 43, a user may rotate the mouthpiece 509 relative to the frontsection 501 of the housing 502, thereby rotating the regulation member579 relative to the chamber inlet bypass 578, to either increase ordecrease the cross-sectional area of the chamber inlet bypass 578through which exhaled air may flow. In this way, the user mayselectively adjust the OPEP device 500 to maintain the ideal operatingconditions.

Sixth Embodiment

Referring to FIGS. 44-45, an OPEP device 600 is shown having a controlport 680 adapted to permit exhaled air to exit the respiratory treatmentdevice 600 prior to entering a first chamber 614 of the OPEP device 600.With the exception of the control port 680, the OPEP device 600 isotherwise configured and operates the same as the OPEP device 100. Asshown, the OPEP device 600 includes a housing 602 comprising a frontsection 601, a middle section 603, and a rear section 605. The housing602 is also associated with a mouthpiece 609, and includes a firstchamber outlet 606 and a second chamber outlet (not shown) positionedopposite the first chamber outlet 606. As seen in the cross-sectionalview of the FIG. 45, the OPEP device 600 includes a restrictor member630 positioned relative to a chamber inlet 604 such that it is moveablebetween a closed position, where the flow of exhaled air through thechamber inlet 604 is restricted, and an open position, where the flow ofexhaled air through the chamber inlet 604 is less restricted, as well asa variable nozzle 636, and a vane 632 operatively connected to therestrictor member 630 by a shaft (not shown). A control port 680 allowsa small amount of exhaled air to exit the respiratory treatment device600 prior to entering the first chamber 614 of the OPEP device 600. Anexemplary flow path 681 through the control port 680 is identified inFIG. 45 by a dashed line. By permitting a small amount of exhaled air toexit the OPEP device 600 through the control port 680, the amplitude andthe frequency of the OPEP therapy administered by the OPEP device 600 isdecreased.

Furthermore, the mouthpiece 609 is rotatable relative to the frontsection 601 of the housing 602 to permit a user to selectively adjustthe amount of exhaled air allowed to exit the respiratory treatmentdevice 600 through the control port 680. For example, as shown in FIG.45, a user may rotate the mouthpiece 609 relative to the front section601 to either increase or decrease the cross-sectional area of thecontrol port 680 through which exhaled air may flow. In this way, theuser may selectively adjust the OPEP device 600 to maintain the idealoperating conditions.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 600.

Seventh Embodiment

Turning to FIGS. 46-47, an OPEP device 700 is shown having a firstcontrol port 780 adapted to permit exhaled air to exit the respiratorytreatment device 700 prior to entering a first chamber 714, and a secondcontrol port 782 adapted to permit exhaled air to exit the respiratorytreatment device 700 from the first chamber 714. With the exception ofthe first control port 780 and the second control port 782, the OPEPdevice 700 is otherwise configured and operates the same as the OPEPdevice 100. As shown, the OPEP device 700 includes a housing 702comprising a front section 701, a middle section 703, and a rear section705. The housing is also associated with a mouthpiece 709, and includesa first chamber outlet 706 and a second chamber outlet (not shown)positioned opposite the first chamber outlet 706. As seen in thecross-sectional view of the FIG. 47, the OPEP device 700 includes arestrictor member 730 positioned relative to a chamber inlet 704 suchthat it is moveable between a closed position, where the flow of exhaledair through the chamber inlet 704 is restricted, and an open position,where the flow of exhaled air through the chamber inlet 704 is lessrestricted, as well as a variable nozzle 736, and a vane 732 operativelyconnected to the restrictor member 730 by a shaft (not shown).

Furthermore, both the first control port 780 and the second control port782 may be equipped with regulation members 779, 783 configured topermit a user to selectively adjust the amount of exhaled air allowed toexit the respiratory treatment device 700 through either the firstcontrol port 780 or the second control port 782. For example, as shownin FIGS. 46-47, the regulation members 779, 783 are formed as a ringconfigured to rotate relative to the housing 702 to either increase ordecrease the cross-sectional area of the control port 780, 782 throughwhich exhaled air may flow. By selectively increasing thecross-sectional area of the first control port 780 through which exhaledair may flow, a user may decrease the amplitude and frequency of theOPEP therapy administered by the OPEP device 700, and vice-versa. Byselectively increasing the cross-sectional area of the second controlport 782, a user may decrease the frequency of the OPEP therapyadministered by the OPEP device 700, and vice-versa. In this way, a usermay selectively adjust the OPEP device 700 to maintain the idealoperating conditions.

Eighth Embodiment

Turning to FIGS. 48-50, another embodiment of an OPEP device 800 isshown. The OPEP device 800 is similar to that of the OPEP device 200 inthat is selectively adjustable. As best seen in FIGS. 48, 50, 53, and62, the OPEP device 800, like the OPEP device 200, includes anadjustment mechanism 853 adapted to change the relative position of achamber inlet 804 with respect to a housing 802 and a restrictor member830, which in turn changes the range of rotation of a vane 832operatively connected thereto. As previously explained with regards tothe OPEP device 200, a user is therefore able to conveniently adjustboth the frequency and the amplitude of the OPEP therapy administered bythe OPEP device 800 without opening the housing 802 and disassemblingthe components of the OPEP device 800. The administration of OPEPtherapy using the OPEP device 800 is otherwise the same as describedabove with regards to the OPEP device 100.

The OPEP device 800 comprises a housing 802 having a front section 801,a rear section 805, and an inner casing 803. As with the previouslydescribed OPEP devices, the front section 801, the rear section 805, andthe inner casing 803 are separable so that the components containedtherein can be periodically accessed, cleaned, or reconfigured, asrequired to maintain the ideal operating conditions. For example, asshown in FIGS. 48-50, the front section 801 and the rear section 805 ofthe housing 802 are removably connected via a snap fit engagement.

The components of the OPEP device 800 are further illustrated in theexploded view of FIG. 51. In general, in addition to the front section801, the rear section 805, and the inner casing 803, the OPEP device 800further comprises a mouthpiece 809, an inhalation port 811, a one-wayvalve 884 disposed therebetween, an adjustment mechanism 853, arestrictor member 830, a vane 832, and a variable nozzle 836.

As seen in FIGS. 52-53, the inner casing 803 is configured to fit withinthe housing 802 between the front section 801 and the rear section 805,and partially defines a first chamber 814 and a second chamber 818. Theinner casing 803 is shown in further detail in the perspective and crosssectional views shown in FIGS. 54-55. A first chamber outlet 806 and asecond chamber outlet 808 are formed within the inner casing 803. Oneend 885 of the inner casing 803 is adapted to receive the variablenozzle 836 and maintain the variable nozzle 836 between the rear section805 and the inner casing 803. An upper bearing 826 and a lower bearing828 for supporting the adjustment mechanism 853 is formed, at least inpart, within the inner casing 803. Like the flexible cylinder 271 andsealing edge 270 described above with regards to the OPEP device 200,the inner casing 803 also includes a flexible cylinder 871 with asealing edge 870 for engagement about a frame 856 of the adjustmentmechanism 853.

The vane 832 is shown in further detail in the perspective view shown inFIG. 56. A shaft 834 extends from the vane 832 and is keyed to engage acorresponding keyed portion within a bore 865 of the restrictor member830. In this way, the shaft 834 operatively connects the vane 832 withthe restrictor member 830 such that the vane 832 and the restrictormember 830 rotate in unison.

The restrictor member 830 is shown in further detail in the perspectiveviews shown in FIGS. 57-58. The restrictor member 830 includes a keyedbore 865 for receiving the shaft 834 extending from the vane 832, andfurther includes a stop 822 that limits permissible rotation of therestrictor member 830 relative to a seat 824 of the adjustment member853. As shown in the front view of FIG. 59, like the restrictor member130, the restrictor member 830 further comprises an offset designed tofacilitate movement of the restrictor member 830 between a closedposition and an open position. More specifically, a greater surface areaof the face 840 of the restrictor member 830 is positioned on one sideof the bore 865 for receiving the shaft 834 than on the other side ofthe bore 865. As described above with regards to the restrictor member130, this offset produces an opening torque about the shaft 834 duringperiods of exhalation.

The adjustment mechanism 853 is shown in further detail in the front andrear perspective views of FIGS. 60 and 61. In general, the adjustmentmechanism includes a frame 856 adapted to engage the sealing edge 870 ofthe flexible cylinder 871 formed on the inner casing 803. A circularopening in the frame 856 forms a seat 824 shaped to accommodate therestrictor member 830. In this embodiment, the seat 824 also defines thechamber inlet 804. The adjustment mechanism 853 further includes an arm854 configured to extend from the frame 856 to a position beyond thehousing 802 in order to permit a user to selectively adjust theorientation of the adjustment mechanism 853, and therefore the chamberinlet 804, when the OPEP device 800 is fully assembled. The adjustmentmechanism 853 also includes an upper bearing 885 and a lower bearing 886for receiving the shaft 834.

An assembly of the vane 832, the adjustment mechanism 853, and therestrictor member 830 is shown in the perspective view of FIG. 62. Aspreviously explained, the vane 832 and the restrictor member 830 areoperatively connected by the shaft 834 such that rotation of the vane832 results in rotation of the restrictor member 830, and vice versa. Incontrast, the adjustment mechanism 853, and therefore the seat 824defining the chamber inlet 804, is configured to rotate relative to thevane 832 and the restrictor member 830 about the shaft 834. In this way,a user is able to rotate the arm 854 to selectively adjust theorientation of the chamber inlet 804 relative to the restrictor member830 and the housing 802. For example, a user may increase the frequencyand amplitude of the OPEP therapy administered by the OPEP device 800 byrotating the arm 854, and therefore the frame 856, in a clockwisedirection. Alternatively, a user may decrease the frequency andamplitude of the OPEP therapy administered by the OPEP device 800 byrotating the adjustment arm 854, and therefore the frame 256, in acounter-clockwise direction. Furthermore, as shown for example in FIGS.48 and 50, indicia may be provided on the housing 802 to aid the user inthe setting of the appropriate configuration of the OPEP device 800.

The variable nozzle 836 is shown in further detail in the front and rearperspective views of FIGS. 63 and 64. The variable nozzle 836 in theOPEP device 800 is similar to the variable nozzle 236 described abovewith regards to the OPEP device 200, except that the variable nozzle 836also includes a base plate 887 configured to fit within one end 885 (seeFIGS. 54-55) of the inner casing 803 and maintain the variable nozzle836 between the rear section 805 and the inner casing 803. Like thevariable nozzle 236, the variable nozzle 836 and base plate 887 may bemade of silicone.

The one-way valve 884 is shown in further detail in the frontperspective view of FIG. 65. In general, the one-way valve 884 comprisesa post 888 adapted for mounting in the front section 801 of the housing802, and a flap 889 adapted to bend or pivot relative to the post 888 inresponse to a force or a pressure on the flap 889. Those skilled in theart will appreciate that other one-way valves may be used in this andother embodiments described herein without departing from the teachingsof the present disclosure. As seen in FIGS. 52-53, the one-way valve 884may be positioned in the housing 802 between the mouthpiece 809 and theinhalation port 811.

As discussed above in relation to the OPEP device 100, the OPEP device800 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 800 isequipped with an inhalation port 811 (best seen in FIGS. 48-49 and51-53) in fluid communication with the mouthpiece 809. As noted above,the inhalation port may include a separate one-way valve 884 (best seenin FIGS. 52-53 and 65) configured to permit a user of the OPEP device800 both to inhale the surrounding air through the one-way valve 884 andto exhale through the chamber inlet 804, without withdrawing themouthpiece 809 of the OPEP device 800 between periods of inhalation andexhalation. In addition, the aforementioned commercially availableaerosol delivery devices may be connected to the inhalation port 811 forthe simultaneous administration of aerosol therapy (upon inhalation) andOPEP therapy (upon exhalation).

The OPEP device 800 and the components described above are furtherillustrated in the cross-sectional views shown in FIGS. 52-53. Forpurposes of illustration, the cross-sectional view of FIG. 52 is shownwithout all the internal components of the OPEP device 800.

The front section 801, the rear section 805, and the inner casing 803are assembled to form a first chamber 814 and a second chamber 818. Aswith the OPEP device 100, an exhalation flow path 810, identified by adashed line, is defined between the mouthpiece 809 and at least one ofthe first chamber outlet 806 (best seen in FIGS. 52-53 and 55) and thesecond chamber outlet 808 (best seen in FIG. 54), both of which areformed within the inner casing 803. As a result of the inhalation port811 and the one-way valve 848, the exhalation flow path 810 begins atthe mouthpiece 809 and is directed toward the chamber inlet 804, whichin operation may or may not be blocked by the restrictor member 830.After passing through the chamber inlet 804, the exhalation flow path810 enters the first chamber 814 and makes a 180° turn toward thevariable nozzle 836. After passing through an orifice 838 of thevariable nozzle 836, the exhalation flow path 810 enters the secondchamber 818. In the second chamber 818, the exhalation flow path 810 mayexit the second chamber 818, and ultimately the housing 802, through atleast one of the first chamber outlet 806 or the second chamber outlet808. Those skilled in the art will appreciate that the exhalation flowpath 810 identified by the dashed line is exemplary, and that airexhaled into the OPEP device 800 may flow in any number of directions orpaths as it traverses from the mouthpiece 809 or chamber inlet 804 tothe first chamber outlet 806 or the second chamber outlet 808. Aspreviously noted, the administration of OPEP therapy using the OPEPdevice 800 is otherwise the same as described above with regards to theOPEP device 100.

Solely by way of example, the follow operating conditions, orperformance characteristics, may be achieved by an OPEP device accordingto the OPEP device 800, with the adjustment dial 854 set for increasedfrequency and amplitude:

Flow Rate (lpm) 10 30 Frequency (Hz) 7 20 Upper Pressure (cm H2O) 13 30Lower Pressure (cm H2O) 1.5 9 Amplitude (cm H2O) 11.5 21The frequency and amplitude may decrease, for example, by approximately20% with the adjustment dial 854 set for decreased frequency andamplitude. Other frequency and amplitude targets may be achieved byvarying the particular configuration or sizing of elements, for example,increasing the length of the vane 832 results in a slower frequency,whereas, decreasing the size of the orifice 838 results in a higherfrequency. The above example is merely one possible set of operatingconditions for an OPEP device according to the embodiment describedabove.Ninth Embodiment

Turning to FIGS. 66-69, another embodiment of a respiratory treatmentdevice 900 is shown. Unlike the previously described OPEP devices, therespiratory treatment device 900 is configured to administer oscillatingpressure therapy upon both exhalation and inhalation. Those skilled inthe art will appreciated that the concepts described below with regardsto the respiratory treatment device 900 may be applied to any of thepreviously described OPEP devices, such that oscillating pressuretherapy may be administered upon both exhalation and inhalation.Likewise, the respiratory treatment device 900 may incorporate any ofthe concepts above regarding the previously described OPEP devices,including for example, a variable nozzle, an inhalation port adapted foruse with an aerosol delivery device for the administration of aerosoltherapy, an adjustment mechanism, a chamber inlet bypass, one or morecontrol ports, etc.

As shown in FIGS. 66 and 67, the respiratory treatment device 900includes a housing 902 having a front section 901, a middle section 903,and a rear section 905. As with the OPEP devices described above, thehousing 902 is openable so that the contents of the housing 902 may beaccessed for cleaning and/or selective replacement of the componentscontained therein to maintain ideal operating conditions. The housing902 further includes a first opening 912, a second opening 913, and athird opening 915.

Although the first opening 912 is shown in FIGS. 66 and 67 inassociation with a mouthpiece 909, the first opening 912 mayalternatively be associated with other user interfaces, for example, agas mask or a breathing tube. The second opening 913 includes a one-wayexhalation valve 990 configured to permit air exhaled into the housing902 to exit the housing 902 upon exhalation at the first opening 912.The third opening 915 includes a one-way inhalation valve 984 configuredto permit air outside the housing 902 to enter the housing 902 uponinhalation at the first opening 912. As shown in greater detail in FIG.67, the respiratory treatment device 900 further includes a manifoldplate 993 having an exhalation passage 994 and an inhalation passage995. A one-way valve 991 is adapted to mount to within the manifoldplate 993 adjacent to the exhalation passage 994 such that the one-wayvalve 991 opens in response to air exhaled into the first opening 912,and closes in response to air inhaled through the first opening 912. Aseparate one-way valve 992 is adapted to mount within the manifold pate993 adjacent to the inhalation passage 995 such that the one-way valve992 closes in response to air exhaled into the first opening 912, andopens in response to air inhaled through the first opening 912. Therespiratory treatment device 900 also includes a restrictor member 930and a vane 932 operatively connected by a shaft 934, the assembly ofwhich may operate in the same manner as described above with regards tothe disclosed OPEP devices.

Referring now to FIGS. 68 and 69, cross-sectional perspective views areshown taken along lines I and II, respectively, in FIG. 66. Therespiratory treatment device 900 administers oscillating pressuretherapy upon both inhalation and exhalation in a manner similar to thatshown and described above with regards to the OPEP devices. As describedin further detail below, the OPEP device 900 includes a plurality ofchambers (i.e., more than one). Air transmitted through the firstopening 912 of the housing 902, whether inhaled or exhaled, traverses aflow path that passes, at least in part, past a restrictor member 930housed in a first chamber 914, and through a second chamber 918 whichhouses a vane 932 operatively connected to the restrictor member 930. Inthis regard, at least a portion of the flow path for both air exhaledinto or inhaled from the first opening 912 is overlapping, and occurs inthe same direction.

For example, an exemplary flow path 981 is identified in FIGS. 68 and 69by a dashed line. Similar to the previously described OPEP devices, therestrictor member 930 is positioned in the first chamber 914 and ismovable relative to a chamber inlet 904 between a closed position, wherethe flow of air through the chamber inlet 904 is restricted, and an openposition, where the flow of air through the chamber 904 inlet is lessrestricted. After passing through the chamber inlet 904 and entering thefirst chamber 914, the exemplary flow path 981 makes a 180-degree turn,or reverses longitudinal directions (i.e., the flow path 981 is foldedupon itself), whereupon the exemplary flow path 981 passes through anorifice 938 and enters the second chamber 918. As with the previouslydescribed OPEP devices, the vane 932 is positioned in the second chamber918, and is configured to reciprocate between a first position and asecond position in response to an increased pressure adjacent the vane,which in turn causes the operatively connected restrictor member 930 torepeatedly move between the closed position and the open position.Depending on the position of the vane 932, air flowing along theexemplary flow path 981 is directed to one of either a first chamberoutlet 906 or a second chamber outlet 908. Consequently, as inhaled orexhaled air traverses the exemplary flow path 981, pressure at thechamber inlet 904 oscillates.

The oscillating pressure at the chamber inlet 904 is effectivelytransmitted back to a user of the respiratory treatment device 900,i.e., at the first opening 912, via a series of chambers. As seen inFIGS. 68 and 69, the respiratory treatment device includes a firstadditional chamber 996, a second additional chamber 997, and a thirdadditional chamber 998, which are described in further detail below.

The mouthpiece 909 and the first additional chamber 996 are incommunication via the first opening 912 in the housing 902. The firstadditional chamber 996 and the second additional chamber 997 areseparated by the manifold plate 993, and are in communication via theexhalation passage 994. The one-way valve 991 mounted adjacent to theexhalation passage 994 is configured to open in response to air exhaledinto the first opening 912, and close in response to air inhaled throughthe first opening 912.

The first additional chamber 996 and the third additional chamber 998are also separated by the manifold plate 993, and are in communicationvia the inhalation passage 995. The one-way valve 992 mounted adjacentto the inhalation passage 995 is configured to close in response to airexhaled into the first opening 912, and open in response to air inhaledthrough the first opening 912.

Air surrounding the respiratory treatment device 900 and the secondadditional chamber 997 are in communication via the third opening 915 inthe housing 902. The one-way valve 984 is configured to close inresponse to air exhaled in to the first opening 912, and open inresponse to air inhaled through the first opening 912.

Air surrounding the respiratory treatment device 900 and the thirdadditional chamber 998 are in communication via the second opening 913in the housing 902. The one way-valve 990 mounted adjacent the secondopening 913 is configured to open in response to air exhaled into thefirst opening 912, and close in response to air inhaled through thefirst opening 912. The third additional chamber 998 is also incommunication with the second chamber 918 via the first chamber outlet906 and the second chamber outlet 908.

Referring now to FIGS. 70-71, cross-sectional perspective views takenalong lines I and II, respectively, of FIG. 66, illustrate an exemplaryexhalation flow path 910 formed between the first opening 912, or themouthpiece 909, and the second opening 913. In general, upon exhalationby a user into the first opening 912 of the housing 902, pressure buildsin the first additional chamber 996, causing the one-way valve 991 toopen, and the one-way valve 992 to close. Exhaled air then enters thesecond additional chamber 997 through the exhalation passage 994 andpressure builds in the second additional chamber 997, causing theone-way valve 984 to close and the restrictor member 930 to open. Theexhaled air then enters the first chamber 914 through the chamber inlet904, reverses longitudinal directions, and accelerates through theorifice 938 separating the first chamber 914 and the second chamber 918.Depending on the orientation of the vane 932, the exhaled air then exitsthe second chamber 918 through one of either the first chamber outlet906 or the second chamber outlet 908, whereupon it enters the thirdadditional chamber 998. As pressure builds in the third additionalchamber 998, the one-way valve 990 opens, permitting exhaled air to exitthe housing 902 through the second opening 913. Once the flow of exhaledair along the exhalation flow path 910 is established, the vane 932reciprocates between a first position and a second position, which inturn causes the restrictor member 930 to move between the closedposition and the open position, as described above with regards to theOPEP devices. In this way, the respiratory treatment device 900 providesoscillating therapy upon exhalation.

Referring now to FIGS. 72-73, different cross-sectional perspectiveviews taken along lines I and II, respectively, of FIG. 66, illustratean exemplary inhalation flow path 999 formed between the third opening915 and the first opening 912, or the mouthpiece 909. In general, uponinhalation by a user through the first opening 912, pressure drops inthe first additional chamber 996, causing the one-way valve 991 toclose, and the one-way valve 992 to open. As air is inhaled from thethird additional chamber 998 into the first additional chamber 996through the inhalation passage 995, pressure in the third additionalchamber 998 begins to drop, causing the one-way valve 990 to close. Aspressure continues to drop in the third additional chamber 998, air isdrawn from the second chamber 918 through the first chamber outlet 906and the second camber outlet 908, As air is drawn from the secondchamber 918, air is also drawn from the first chamber 914 through theorifice 938 connecting the second chamber 918 and the first chamber 914.As air is drawn from the first chamber 914, air is also drawn from thesecond additional chamber 997 through the chamber inlet 904, causing thepressure in the second additional chamber 997 to drop and the one-wayvalve 984 to open, thereby permitting air to enter the housing 902through third opening 915. Due to the pressure differential between thefirst additional chamber 996 and the second additional chamber 997, theone-way valve 991 remains closed. Once the flow of inhaled air along theinhalation flow path 999 is established, the vane 932 reciprocatesbetween a first position and a second position, which in turn causes therestrictor member 930 to move between the closed position and the openposition, as described above with regards to the OPEP devices. In thisway, the respiratory treatment device 900 provides oscillating therapyupon inhalation.

Referring now to FIG. 74, a front perspective view is shown of the OPEPdevice 800 connected with an aerosol delivery device in the form of anebulizer 899 via the inhalation port 811. The system comprising theOPEP device 800 connected to the nebulizer 899 is configured to provideboth oscillating pressure therapy and aerosol therapy, as describedabove. The combination of the OPEP device 800 and the nebulizer 899,however, is exemplary. Alternative combinations of the OPEP devicesdescribed herein and aerosol delivery devices, such as those identifiedabove, are also envisioned.

Those skilled in the art will appreciated that the various conceptsdescribed above with regards to a particular embodiment of an OPEPdevice may also be applied to any of the other embodiments describedherein, even though not specifically shown or described with regards tothe other embodiments. For example, any one of the embodiments describedherein may include a variable nozzle, an inhalation port adapted for usewith an aerosol delivery device for the administration of aerosoltherapy, an adjustment mechanism for adjusting the relative position ofthe chamber inlet and/or the permissible range of movement by arestrictor member, a chamber inlet bypass, one or more control ports,etc.

Although the foregoing description is provided in the context of an OPEPdevice, it will also be apparent to those skilled in the art will thatany respiratory device may benefit from various teachings containedherein. The foregoing description has been presented for purposes ofillustration and description, and is not intended to be exhaustive or tolimit the inventions to the precise forms disclosed. It will be apparentto those skilled in the art that the present inventions are susceptibleof many variations and modifications coming within the scope of thefollowing claims.

Exemplary Implementations

In one implementation, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveexhaled air into the at least one chamber, and at least one chamberoutlet configured to permit exhaled air to exit the at least onechamber. An exhalation flow path is defined between the chamber inletand the at least one chamber outlet, and a restrictor member ispositioned in the exhalation flow path, the restrictor member beingmoveable between a closed position, where a flow of exhaled air throughthe chamber inlet is restricted, and an open position, where the flow ofexhaled air through the chamber inlet is less restricted. An orifice ispositioned along the exhalation flow path through which the exhaled airpasses, and a vane is positioned adjacent the orifice, the vane beingoperatively connected to the restrictor member, and configured toreciprocate between a first position and a second position in responseto an increased pressure adjacent the vane. Additionally, the restrictormember moves between the closed position and the open position inresponse to the vane reciprocating between the first position and thesecond position.

The restrictor member may be positioned in a first chamber, and the vanemay be positioned in a second chamber. The orifice may connect the firstchamber and the second chamber. A size of the orifice may be configuredto change in response to the flow of exhaled air through the orifice.The restrictor member may be a butterfly valve. The vane may beoperatively connected to the restrictor member by a shaft. A face of therestrictor member may be rotatable about an axis of rotation, and theface of the restrictor member may be radially offset from the axis ofrotation. The face of the restrictor member may also have a greatersurface area positioned on one side of the shaft than on the other sideof the shaft. An orientation of the chamber inlet may be selectivelyadjustable. A chamber inlet bypass may be configured to permit exhaledair into the at least one chamber without passing through the chamberinlet. A control port may be configured to permit exhaled air to exitthe respiratory treatment device prior to entering the at least onechamber. A control port may also be configured to permit exhaled air toexit the first chamber. An inhalation port may be in fluid communicationwith a user interface, and a one-way valve may be configured to permitair to flow through the inhalation port to the user interface uponinhalation. The inhalation port may also be configured to receive anaerosol medicament from an aerosol delivery device. The exhalation flowpath may be folded upon itself.

In another implementation, a method of performing OPEP therapy includesreceiving a flow of exhaled air along an exhalation flow path definedbetween an inlet and an outlet of a respiratory treatment device,directing the flow of exhaled air toward a vane, reciprocating the vanebetween a first position and a second position in response to the flowof exhaled air, and, moving a restrictor member in response to thereciprocal movement of the vane between a closed position, where a flowof exhaled air through the chamber inlet is restricted, and an openposition, where the flow of exhaled air through the chamber inlet isless restricted.

In another implementation, a method of performing OPEP therapy includesreceiving a flow of exhaled air along an exhalation flow path definedbetween an inlet and an outlet of a respiratory treatment device,accelerating the flow of exhaled air through an orifice positioned alongthe exhalation flow path, reciprocating a vane adjacent the orificebetween a first position and a second position in response to the flowof exhaled air through the orifice, and, moving a restrictor member inresponse to the reciprocal movement of the vane between a closedposition, where the flow of exhaled air along the exhalation flow pathis restricted, and an open position, where the flow of exhaled air alongthe exhalation flow path is less restricted. The method may also includechanging a size of the orifice in response to the flow of exhaled airthrough the orifice.

What is claimed is:
 1. A respiratory treatment device comprising: ahousing enclosing at least one chamber; a chamber inlet configured toreceive exhaled air into the at least one chamber; at least one chamberoutlet configured to permit exhaled air to exit the at least onechamber; an exhalation flow path defined between the chamber inlet andthe at least one chamber outlet; a restrictor member positioned in theexhalation flow path, the restrictor member moveable between a closedposition, where a flow of exhaled air along the exhalation flow path isrestricted, and an open position, where the flow of exhaled air alongthe exhalation flow path is less restricted; and, a vane in fluidcommunication with the exhalation flow path, the vane operativelyconnected to the restrictor member and configured to reciprocate betweena first position and a second position in response to a flow of exhaledair along the exhalation flow path; wherein the restrictor member andthe vane are axially offset along a common axis of rotation.
 2. Therespiratory treatment device of claim 1, wherein in the first positionthe vane is positioned to direct the flow of exhaled air to exit the atleast one chamber through a first chamber outlet of the at least onechamber outlet, and in the second position the vane is positioned todirect the flow of exhaled air to exit the at least one chamber througha second chamber outlet of the at least one chamber outlet.
 3. Therespiratory treatment device of claim 1, wherein the restrictor memberis positioned in a first chamber and the vane is positioned in a secondchamber.
 4. The respiratory treatment device of claim 3, wherein thefirst chamber and the second chamber are connected by an orifice.
 5. Therespiratory treatment device of claim 4, wherein a size of the orificeis configured to change in response to the flow of exhaled air throughthe orifice.
 6. The respiratory treatment device of claim 1, wherein therestrictor member is a butterfly valve.
 7. The respiratory treatmentdevice of claim 1, wherein the vane is operatively connected to therestrictor member by a shaft.
 8. The respiratory treatment device ofclaim 7, wherein a face of the restrictor member is rotatable about anaxis of rotation.
 9. The respiratory device of claim 8, wherein the faceof the restrictor member is radially offset from the axis rotation. 10.The respiratory device of claim 8, wherein the face of the restrictormember has a greater surface area positioned on one side of the shaftthan on the other side of the shaft.
 11. The respiratory treatmentdevice of claim 1, wherein an orientation of the chamber inlet isselectively adjustable.
 12. The respiratory treatment device of claim 1,further comprising a chamber inlet bypass configured to permit exhaledair into the at least one chamber without passing through the chamberinlet.
 13. The respiratory treatment device of claim 1, furthercomprising a control port configured to permit exhaled air to exit therespiratory treatment device prior to entering the at least one chamber.14. The respiratory treatment device of claim 3, further comprising acontrol port configured to permit exhaled air to exit the first chamber.15. The respiratory treatment device of claim 1, further comprising aninhalation port in fluid communication with a user interface.
 16. Therespiratory treatment device of claim 15, further comprising a one-wayvalve configured to permit air to flow through the inhalation port tothe user interface upon inhalation.
 17. The respiratory treatment deviceof claim 15, wherein the inhalation port is adapted to receive anaerosol medicament from an aerosol delivery device.
 18. The respiratorytreatment device of claim 1, wherein the exhalation flow path is foldedupon itself.
 19. The respiratory treatment device of claim 17, whereinthe aerosol delivery device is connected to the inhalation port.
 20. Arespiratory treatment device comprising: a housing enclosing at leastone chamber; a chamber inlet configured to receive exhaled air into theat least one chamber; at least one chamber outlet configured to permitexhaled air to exit the at least one chamber; an exhalation flow pathdefined between the chamber inlet and the at least one chamber outlet; arestrictor member positioned in the exhalation flow path, the restrictormember moveable in response to a flow of exhaled air along theexhalation flow path between a closed position, where the flow ofexhaled air along the exhalation flow path is restricted, and an openposition, where the flow of exhaled air along the exhalation flow pathis less restricted; and, a variable nozzle positioned in the exhalationflow path such that the exhalation flow path passes through an orificeof the variable nozzle, wherein a size of the orifice is configured toincrease in response to the flow of exhaled air through the orifice. 21.The respiratory treatment device of claim 20, further comprising a vanepositioned adjacent the orifice, the vane being operatively connected tothe restrictor member and configured to move the restrictor memberbetween the closed position and the open position in response to anincreased pressure adjacent the vane.
 22. The respiratory treatmentdevice of claim 20, wherein the variable nozzle is positioned downstreamfrom the restrictor member in the exhalation flow path.
 23. Therespiratory treatment device of claim 20, wherein the orifice of thevariable nozzle is substantially rectangular.
 24. The respiratorytreatment device of claim 21, wherein the orifice of the variable nozzleremains substantially rectangular after an increase in the size of theorifice in response to the flow of exhaled air through the orifice. 25.The respiratory treatment device of claim 20, wherein an orientation ofthe chamber inlet is selectively adjustable.
 26. The respiratorytreatment device of claim 20, further comprising a chamber inlet bypassconfigured to permit exhaled air into the at least one chamber withoutpassing through the chamber inlet.
 27. The respiratory treatment deviceof claim 20, further comprising a control port configured to permitexhaled air to exit the respiratory treatment device prior to enteringthe at least one chamber.
 28. The respiratory treatment device of claim20, further comprising an inhalation port in fluid communication with auser interface.
 29. The respiratory treatment device of claim 28,further comprising a one-way valve configured to permit air to flowthrough the inhalation port to the user interface upon inhalation. 30.The respiratory treatment device of claim 28, wherein the inhalationport is adapted to receive an aerosol medicament from an aerosoldelivery device.
 31. The respiratory treatment device of claim 20,wherein the exhalation flow path is folded upon itself.
 32. Therespiratory treatment device of claim 31, wherein the aerosol deliverydevice is connected to the inhalation port.